Halaven

INDICATIONS

HALAVEN is indicated for the
treatment of patients with metastatic breast cancer who have previously
received at least two chemotherapeutic regimens for the treatment of metastatic
disease. Prior therapy should have included an anthracycline and a taxane in
either the adjuvant or metastatic setting.

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended dose of HALAVEN
is 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days
1 and 8 of a 21-day cycle.

The recommended dose of HALAVEN
in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m² administered
intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use
in Specific Populations].

The recommended dose of HALAVEN
in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m² administered
intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use
in Specific Populations].

The recommended dose of HALAVEN
in patients with moderate renal impairment (creatinine clearance of 30-50
mL/min) is 1.1 mg/m² administered intravenously over 2 to 5 minutes
on Days 1 and 8 of a 21-day cycle [seeUse in Specific Populations].

Instructions For Preparation And
Administration

Aseptically withdraw the
required amount of HALAVEN from the single-use vial and administer undiluted or
diluted in 100 mL of 0.9% Sodium Chloride Injection, USP.

Do not dilute in or
administer through an intravenous line containing solutions with dextrose. Do not administer in the
same intravenous line concurrent with the other medicinal products.

Store undiluted HALAVEN in the
syringe for up to 4 hours at room temperature or for up to 24 hours under
refrigeration (40°F or/ 4°C). Store diluted solutions of HALAVEN for up to 4
hours at room temperature or up to 24 hours under refrigeration.

Discard unused portions of the
vial.

HOW SUPPLIED

Dosage Forms And Strengths

HALAVEN (eribulin mesylate)
Injection, 1 mg/2 mL (0.5 mg/mL).

Storage And Handling

NDC 62856-389-01 Eribulin
mesylate injection, 1 mg/2 mL, in a single-use vial. One vial per carton. Store
at 25°C (77°F); excursions permitted to 15° – 30° C (59° -86° F). Do not
freeze. Store the vials in their original cartons.